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Title: Thalidomide Found Similar to Intravenous Chemotherapy in Heavily Pretreated Patients With Advanced Ovarian Cancer: Presented at SGO

"Thalidomide Found Similar to Intravenous Chemotherapy in Heavily Pretreated Patients With Advanced Ovarian Cancer: Presented at SGO"

By Karla Harby MIAMI BEACH, FL -- March 21, 2005 -- Oral thalidomide has been found to be similar in effectiveness and toxicity to intravenous chemotherapy in advanced, recurrent ovarian cancer, and may offer an alternative to intravenous (IV) platinum-based chemotherapy. However, in this series of 40 patients, investigators led by Mary E. Gordinier, MD, assistant professor, Women and Infants Hospital, Providence, Rhode Island, United States, there were no complete responses regardless of treatment. Dr. Gordinier presented her findings here on March 20[^th at the 2005 Annual Meeting on Women's Cancer of the Society of Gynecologic Oncologists.

In this prospective study, patients and their physicians selected their own treatment from three choices: any standard single-agent IV therapy, oral thalidomide at 200 mg daily, or no treatment.

Dr. Gordinier noted that only 4 of 40 patients chose a treatment holiday. "Our patients prefer treatment," she said.

At the outset, 18 patients chose IV chemotherapy and 18 patients chose thalidomide. Of the 15 evaluable patients on IV therapy, one experienced a partial response, nien had stable disease and five had disease progression. For the 13 evaluable patients on thalidomide, one experienced a partial response, seven had stable disease and five had disease progression.

When the researchers compared the patients on thalidomide and those on IV chemotherapy, they found no statistically significant difference in the progression-free interval, which was 3 to 4 months regardless of treatment. The researchers observed no difference in quality of life in the treated groups, but the patients who declined treatment reported a better quality of life.

Among patients on thalidomide, eight experienced shortness of breath as a toxicity, Dr. Gordinier said. This was not surprising because of thalidomide's previously reported effects on lung function. In addition, she said, two patients on thalidomide developed grade-2 sedation, and two developed grade 3 to 4 constipation, while one patient was later found to have a pseudo-obstruction that required bowel resection.

Patients were eligible for the study if they had recurrent ovarian cancer after 2 prior regimens for recurrence. The researchers acquired computed tomography scans every two cycles and monitored CA-125 levels. Quality of life was assessed monthly using the Functional Assessment of Cancer Therapy-Ovarian questionnaire.

Oral thalidomide may be reasonable, especially for patients who prefer to avoid additional intravenous therapy, Dr. Gordinier concluded.

[Presentation title: Chemotherapy, Thalidomide, or Treatment Holiday for Advanced Ovarian Cancer: a Prospective Study. Abstract 11]

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